Customizable, self holding, space retracting arthroscopic/endoscopic cannula system

ABSTRACT

The present invention is directed to a device including an inner cannula having one or more wings or leaflets attached to one end thereof. The wings or leaflets can be cut to length or shaped to facilitate holding the operative field open for optimal visualization and the use of surgical instruments. A shorter, outer cannula is fitted over the inner cannula and a flange attached to the outer cannula is moved from a closed position in which the wings are covered by the inner surface of the cannula or to an open, deployed position in which the wings are opened. The outer cannula may be textured or shaped to aid in holding the desired position. The device also includes a dam or barrier at the end or other convenient location in the inner cannula to control the flow of air or fluids in the cannula as to make it useful in arthroscopic or endoscopic surgery of all types. The wings or leaflets can have mating tapered tips that joint into a single tip when closed or an optional trocar to ease insertion into the desired body cavity. The design allows for manufacture at almost any size to make the device useful in the widest of surgical applications and in all joint or body cavities large or small.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a division of U.S. patent application Ser.No. 12/662,952 filed May 13, 2010, entitled “CUSTOMIZABLE, SELF HOLDING,SPACE RETRACTING ARTHROSCOPIC/ENDOSCOPIC CANNULA SYSTEM, which iscurrently pending, which claims the benefit of provisional patentapplication Ser. No. 61/272,089, filed on Aug. 14, 2009 and isincorporated by reference herein.

FIELD OF THE INVENTION

The present invention is directed to a cannula used for a multitude ofmedical and surgical procedures.

BACKGROUND OF THE INVENTION

During arthroscopic surgery there is a well established need forcannulae for a wide variety of procedures. These include, but are notlimited to procedures in all of the joints treated by arthroscopictechniques. To meet this need, there are a number of cannulae availablewith a number of differing designs to control fluid flow, preventslippage of the cannula and allow passage of instruments, sutures,implants, anchors or fiber-optic devices to and from the site of theprocedure. In the past a design feature with expandable wings thatengage the subcutaneous tissues to help hold the cannula in place hasbeen developed. Unfortunately these wings are often larger than thespace available in various locations of the body, such as joints and arenot suited to be used in small spaces in the body. These prior artdevices cannot accommodate the shape of the individual joint spaces.Further, these prior art mechanisms require a recess from the tip of thecannula, or a weakness of the attachment for its functionality, such asdescribed in U.S. Pat. No. 6,325,812, issued to Dubrul. Furthermore, themechanical design of the hinged flaps of the prior art devices cannot beshortened or changed at the time of surgery by the surgeon toaccommodate the shape of the joint or to directly aid in exposing thesurgical sight of interest.

More importantly there is a current need, well known to those familiarin the advanced form of the art, for internal retraction of the softtissue allow for a reduction of the fluid pressures required to distendor open the joint space. Such a system would allow for longer operativetimes and therefore allow more sophisticated and complex procedures tobe completed using less fluid at a lower pressure inside a joint spaceto distend the joint. This would reduce the need for absolute seals atthe ends of the cannula, as well as reduce the complications associatedwith high pressure fluid pumps as well as the resultant fluidextravasations into the local extra-articular tissues in order to keepthe joint or body cavity space open. This would also decrease the riskof skin complications, loss of visualization and nerve damage in themore complex cases requiring longer operative times. The flexible wingdesign of the present invention would produce customizable soft tissueretractors that would service this purpose. A device with these featureswould increase safety with longer surgical times or more complexprocedures thereby advancing the state of the art. Furthermore, there isa need in the state of the art to have a device of this type with asufficiently simple design as to allow for inexpensive manufacture ormass production in a multitude of sizes and configurations toaccommodate many differing joints or body cavities.

Therefore, with that in mind, there is a need in the current art for aself, holding cannula that could be manufactured in any size, and becustomizable at the time of surgery that has the advantages outlinedbelow.

SUMMARY OF THE INVENTION

The present invention is constructed using an inner tabular cannulainserted within a shorter outer cannula, with an outer cannulalongitudinally moving with respect to the inner cannula.

The present invention overcomes the deficiencies of the prior art byproviding an endoscopic/arthroscopic, surgical utility cannula havingvarious advantages over various prior art devices and methods of usecurrently on the market. This is accomplished by providing a cannulahaving self-holding wings connected to the distal end of the innercannula for the purpose of stabilizing the cannula in or around theoperative portal while retracting the nearby soft tissues. The actualsize and dimensions of the cannula would be designed based upon theparticular portal, joint, or other portion of the body into which thecannula would be inserted. Obviously, smaller joints could onlyaccommodate a relatively small cannula and larger joints would require abigger cannula. The number of wings that are provided to stabilize thecannula would be based upon the particular application. Therefore, thecannula, according to the present invention, can be provided with one ormore wings. The orientation, length and spacing of the wings are notpredetermined by the mechanical design which would allow for theexpansion of the cannula, either by internal expansion or by theexternal folding of the wings. The wings can vary in size, length, shapeand/or positional relationship based upon the operative portal or thejoint to be treated. The present invention would include embodimentswith pre-made “wings,” “flaps,” “leaflets” or “tabs” with differinglengths to match specific joints of the anatomy or the need of aspecific procedure to be performed. The wings can be in any number offorms including curve or straight ends to allow for a number of trocartips that can be sharp, dull, rounded or other shape to allow for easeof use for a given application. Furthermore, the wings need not betapered. The design therefore can be produced in a multitude ofconfigurations matching the needs of a great variety of internal bodyspaces or joint spaces requiring cannulation and many differingprocedures.

The wings of the cannula of the present invention can be altered as manytimes as needed by any number of common cutting instruments available tothe surgeon for the surgical procedure to create the correct fit before,or during the procedure. In particular if the device is placed and thefit is not optimal, the device can be modified on the surgical field asmany times as needed to meet the demand of the procedure. The device cancontain one or more conical or pyramidal shaped tips on one or more ofthe wings to create a tapered front when not deployed, for the purposeof easing the insertion of the cannula into the joint. The wings cancontain tapered tips that mate with the trocar tip used to ease theinsertion of the cannula into the joint.

The inner and outer surfaces of the cannula can be provided with anynumber of stops or notches to hold the cannula in an open or a closedposition during use. Furthermore, the outer surface can be treated withany number of known or novel surface treatments, such as ridges, bumps,screw-like threads, spines or coatings to add in the passage or frictionfit of the cannula in the soft tissue portal.

The material of the inner sleeve and wings of the cannula can beconstructed from any material that can be cut by surgical cutters,scissors, scalpels or a number of surgical instruments available on thesurgical field to the surgeon at the time of the procedure. Therefore,the length of the wings can be cut or adjusted by the surgeon usingcommon surgical instruments. This enables the surgeon to produce adevice to best take advantage of the present invention's benefits in aspace of almost any configuration. The stabilized cannula of the presentinvention holds its place and the leaflets allow for a smooth transitionfrom the cavity to the inner lumen, thereby easing the passage ofsutures, fluids and surgical instruments for the desired endoscopic orarthroscopic surgical procedures. This feature would make passage ofsutures, instruments, fluids, graft materials, scaffolds, biologicimplants, autograft or allograft material, suture devices, knot pushers,drills, wires, pins, endoscopic or arthroscopic instruments and/oranchoring devices easier and will advance the state of the art. Thepre-formed inner wings can be deployed in any desired joint space,abdominal cavity or sub-muscular space. Consequently, the deployed wingscan expand the effective diameter of the end of the cannula andtherefore can stabilize the cannula in position, while creating a smoothtransition from the body cavity or space to the inner lumen of thecannula.

The cannula, according to the present invention, can be constructed fromvarious materials, such as, but not limited to different types ofrubber, plastics, thermoplastics, Teflon, or various other metals suchas copper, aluminum or stainless steel.

As in all other cannulae, the outside surface of the outer cannula canbe treated or manufactured with textured, rough, smooth, threaded,ribbed or other surface covers which would aid in holding the cannula inplace during the procedure.

The cannula has a fitted trocar that accommodates the leaflets and isdesigned to aid cannula insertion into a joint, submuscular space or abody cavity for the purposes of arthroscopic or endoscopic surgery. Thetrocar would fit smoothly inside the inner cannula, providing a tip toease incertion of the device. The separate inner trocar can lock inplace to ease insertion. The trocar's tip can be any number of shapes,smooth, rounded, oblong, pointed, sharp or have a cutting edge withoutaltering the function of the leaflets. At the same time, any number ofthe leaflets can be cut part way or fully without impeding the functionof the inserting trocar. This allows for ease of insertion whilemaximizing the stabilizing quality of the invention presented in a widevariety of joint or body cavities as in, but not limited to shoulder,elbow, and ankle arthroscopic procedures.

The cannula wings would be sturdy enough so the cannula can also beinserted in a closed position, opened fully and partly backed out withwings still in a deployed position to further retract the soft tissuesout of the operative field. The sturdy wings would also keep the cannulafirmly in place. The curved shape of the open wings would also aid inthe smooth insertion and removal of operative instruments. In thismanner improve the operative view while reducing the amount of normaltissue removed during the surgical attempt to visualize the operativefield.

It is a further object of this invention to provide a cannula systemthat can be used in any number of sizes, lengths and even opening shapesother than those used in the prior art such as a round, oval, oblong orrectangular opening. The outer end of the cannula can be open or coveredwith any number of flexible coverings or dams to hold fluids in whileallowing passage of instruments, sutures or materials required for thedesired procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

The device of the present invention will be described in more detailhereinafter in conjunction with the drawings wherein:

FIG. 1 is a drawing showing the cannula in the closed position with thewings provided within the cannula;

FIG. 2 is a drawing showing the cannula of FIG. 1 in an open positionwith the wings deployed;

FIG. 3 is an expanded view of a cannula showing a trocar, inner andouter cannula in configuration for insertion into body cavity;

FIG. 4 is a drawing of one embodiment of the outer cannula with athreaded outside texture;

FIG. 5 is a drawing of one embodiment of the inside cannula showing thefluid dam, ridges to hold the outer cannula in the proximal positionwhen wings are deployed;

FIG. 6 is a drawing of one possible trocar shape;

FIG. 7 a is a drawing showing one embodiment the wings with matingconical/pyramidal tips in the closed position with the tips mated intoone single point to ease insertion before deployment;

FIG. 7 b shows the conical/pyramidal tips in the open position afterdeployment;

FIG. 7 c shows the conical/pyramidal tips in the open position with thetapered mating tips on only two of the wings or leaflets;

FIG. 7 d shows the conical/pyramidal tip in the open position with atapered tip only on one wing or leaflet;

FIG. 8 a shows one embodiment with equal leaflets or wings deployedwithout conical tips;

FIG. 8 b is a drawing of the wings deployed with two wings cut orpremade to a shorter length to accommodate a specific application oruse;

FIGS. 9 a, b, and c are drawings showing various textures provided onthe outer surface of the cannula;

FIGS. 10 a, 10 b, 10 c and 10 d are drawings of possible embodimentswith differing cross sectional shapes to accommodate differentapplications;

FIG. 11 a is a drawing of one embodiment with a particular custom shapedwing and the custom irregular shaped wings in the deployed position;

FIG. 11 b is a drawing with the custom irregular shaped wings in theclosed position;

FIG. 12 a is a cross-sectional view of a second embodiment of thepresent invention using an insertion tip being formed partly from thewings and partly from the tip of the trocar;

FIG. 12 b is an end view of the device shown in FIGS. 3 and 12 a;

FIG. 13 is a drawing of the cannula in place through the skin, into ajoint space and with wings deployed retracting the fat pad inside thejoint space allowing for better visualization of the joint itself; and

FIG. 14 is a drawing showing the manner in which the tips are shaped.

BRIEF DESCRIPTION OF THE PRESENT INVENTION

As Illustrated in FIGS. 1-4, the cannula 1 of the present inventionincludes two concentric cannulae including an inner cannula 10 and anouter cannula 4 having a distal end 20, the outer cannula 4 fitting overthe inner cannula 10. The inner cannula 10 is longer than the outercannula 4 and is provided with an open flange or a water dam 2 at aproximal end of the inner cannula 10 shown in FIGS. 2 and 5. The fluidor water dam 2 could exhibit many configurations as is commonly used onprior art cannulae. The distal end of the inner cannula 10 is providedwith a plurality of wings 6 as shown in FIG. 2. The number, shape andlength of these wings would be based upon the particular application ofthe cannula. For example, FIG. 5 shows tips with partially pointed tips6, and FIGS. 7 a-7 d show the use of conical tips 12. Each of the tipsor wings provided on the distal end of the inner cannula, need not beequal in size, or even shape. For example, FIG. 8 a has a plurality oftips or wings 6 equal in size to each other, whereas FIG. 8 billustrates wings or tips 14 shorter than wings or tips 6. As can beappreciated, the length of each of the wings or tips 6 could be ofunequal size or shape to the other wings or tips.

The second, shorter outer cannula 4, as shown in FIG. 2, would beprovided with a flange 8 used in a sliding motion to deploy the wings 6to move the outer cannula 4 over the inner cannula 10, when the flange 8is moved to the left, as depicted by arrow 3. When the flange 8 is movedto the right, as shown by arrow 5 in FIG. 1, and in cross section inFIG. 12, the wings 6 would be closed or protected within the outercannula 4. This facilitates device insertion and removal to or fromvarious parts of the body, such as, but not limited to joints. FIG. 2illustrates how the wings 6 curve away from the inner lumen 18 of theinner cannula 10 making a smooth transition between the open space andthe cannula lumen.

FIG. 5 illustrates an embodiment wherein the outer surface of the innercannula 10 may be provided with various notches, ridges, rings 40 orother devices to lock the flange 8 in the open and closed positions,making the open and closed positions more obvious and apparent to thesurgeon. The outer surface of the outer cannula 4 can also be providedwith various threads 24 notches, ridges, rings 26 or other textures 28to create more friction between the skin and the outer wall of the outercannula 4 to help hold it in place. These features are illustrated inFIGS. 1-4 and FIGS. 9 a, 9 b and 9 c. The cannula 1 can be constructedin many shapes such as round, oval, square, rectangular or many othershapes. FIGS. 10 a-d illustrate some, but not all of the potentialshapes.

FIG. 6 illustrates one possible embodiment of a standard inner trocar 22for aid in inserting the cannula 1 into a particular location in thebody. The shape of the trocar can be altered to accommodate the wingtips or not required if the conical configuration is used shown in FIGS.7 a-d. In the conical tip embodiments shown in FIGS. 7 c-d, the trocartip is built into the wing or tip design and this eliminated a componentwhich my simplify the manufacture of the cannula and provide a costadvantage. The cannula is inserted into the body by pushing the tip 42of the trocar against the water or fluid dam 2 when the cannula is inthe closed position as shown in FIG. 1.

The wings 6 should be constructed from a material which is flexibleenough to be constrained by the outer cannula 4 when it is in the closedposition as shown in FIG. 1, while retaining a curved shape when it isopened as illustrated with respect to FIG. 2. The material of the wings6 should be soft enough to be cut or shaped by scissors of any type orby any special type of cutting device available to a surgeon foroperative use, such as, but not limited to, plastic, paper, foam,composite materials and/or soft metals like copper, aluminum or tin. Theouter surface of each of the wings can be treated to change the holdingpower or friction of the wings. However, the material of the wings 6should be firm enough to aid as a soft tissue retractor for any numberof specific procedures while stabilizing the cannula position as asurgical portal allowing fluids to be introduced as well as othersurgical tools. The wings 6 can be reinforced by wire, springs orvarious types of memory metals or other stiff material to help supporttheir shape.

The relative orientation of the wings or tips 6 are not predetermined bythe mechanical design that allows further expression of the wings ortips 6 when deployed. The wings can vary in size, length, shape and/orpositioned relationship can be made for specific joints, and can bealtered many times as needed during the procedure. The shape and lengthof each wing can be trialed tested, reshaped and retested on theoperative field using common surgical instruments. The shape can also bemanufactured to specifications for any of a multitude of uses.

As shown in FIG. 13, the wings 6, by virtue of their shape, with orwithout customization, can act as internal retractors of the softtissues of the body. This would facilitate more sophisticated andcomplex procedures. These procedures could also be completed using lessfluid at a lower pressure in order to distend a joint. Operating at alower pressure would reduce pressure related fluid extravasations intothe local extra-articular tissues. This would decrease the fluid relatedrisks of nerve damage, skin complications and loss of jointvisualization in longer, more complex cases. The flexible wing designproposed here could act soft tissue retractors that would serve thispurpose. If the flexible wings fit are not optimal, the device can bemodified on the surgical field, with common surgical instruments, asmany times as needed to meet the demand of the procedure. The wings canalso be precut, premade or manufactured in varied lengths or shapes forspecific procedures. The design therefore can be produced in a multitudeof configurations matching the needs of a great variety of internal bodyspaces or joint spaces requiring cannulation and many differingprocedures.

FIG. 14 illustrates the manner in which the tips or wings 6 are modifiedprior to or during the procedure. Generally, once the operative site isvisualized, the surgeon will be able to determine the size and shape ofall of the tips or wings 6. A scissor 38, or any other sharp implementwould be used to cut and shape one or more of the tips or wings 6.

The device, when deployed through the skin 32, as shown in FIG. 13, isdesigned to hold its place in the joint space 36 while maintainingaccess to the desired cavity, aid in fluid flow control, preventslippage of the cannula out of place and allow easy passage ofinstruments, sutures, anchors, graft materials and/or fiber-optic scope.The wings can then retract soft tissues inside the joint space such as afat pad or synovium 34.

FIG. 11 a shows the wings 30 when they are deployed, and FIG. 11 b showsthe wings when they are retracted within the outer cannula. As shown inFIGS. 11 a and 11 b, the wings 6 can be custom made or pre-shaped 30 toaccommodate the individual surgical spaces (i.e. shoulder, knee, elbow,abdomen etc.), as needed to best aid the procedure, at the time ofsurgery by the surgeon. If the fit is unsatisfactory, an unlimited rangeof changes can be made on the surgical field to fit the surgical sightof interest.

FIGS. 7 a-d show the use of the present invention when provided withconical tips 12 attached to one or more of the ends of the wings 6. FIG.7 a shows the cannula 1 in a closed position with the cones 12 mated andextending from the end of the inner cannula 10, but still restrained bythe outer cannula 4 from being deployed. It can be appreciated thatvarious shapes, such as a pyramidal shape, can be attached to the end ofone or more of the wings 6. As illustrated in FIG. 7 a, when thisembodiment is in the closed position, the tips 12 would merge to asingle point and allow for self-insertion into the body. The tips 12 canalso act as an aid in tissue retraction, as shown in FIGS. 7 b-d, whenthe wings or tips are fully deployed. As shown in FIGS. 7 c and 7 d, thecannula tips 12 need not be included on each of the wings or tips 6.

The outer surface of the outer cannula 4 can be covered with any numberof surfaces, as shown in FIGS. 9 a, b and c. FIG. 9 a shows the use of athreaded exterior 24, 9 b shows a plurality of ribs or ridges 26extending over the entire length of the cannula 4 or a portion of thelength of the cannula 4. Similarly, the outer surface of cannula 4 canbe textured 28 as shown in FIG. 9 c. Similar to the threaded surface 24of FIG. 9 a, the ribbed surface 26 as well as the textured surface 28 ofFIG. 9 c can extend part way along the cannula or along the entirelength of the outer cannula 4, or for any portion or segment of thatlength.

FIGS. 3 and 12 show an alternate embodiment of the present invention inwhich the wings have part of the trocar tip and the trocar has thebalance end point. In the embodiments shown in FIGS. 3 and 12, the tipsof the wings 6 mate with the edge out with a third component being aninner trocar. In this case, as shown in FIG. 8, the trimming of thewings to shape would no longer alter the trocar tip, making it easier toinsert the device into the desired space. This is shown in FIG. 12 inwhich the tips 12 mate with the second end 20 of the outer cannula 4 andthe trocar 22. In this case, the trimming of the wings to shape would nolonger alter the trocar tip making it easier to insert the device intothe desired space.

Both the inner cannula 10 as well as the outer cannula 4 can beconstructed from any materials used in the past to construct cannulae.These materials include, but are not limited to, natural rubber,synthetic rubber, plastics, thermoplastics, Teflon® or metals, such asaluminum, copper, stainless steel, or other alloys. Based upon the fieldof use, the cannulae can be rigid or flexible in their totality or canexhibit rigid or flexible portions along the lengths of the cannulae 4and 10. The cannulae could also be constructed from elastomeric materialand can be fully disposable, partly reusable or rally reusable aftersterilization. The elastomeric material can be provided as a coating orpresent throughout the cannula. The either cannula can be made of amaterial in the class of any of the “memory metals” or materials thatchange shape with the environmental temperature to facilitate use incertain body cavities or to aid in the deployment of the “wings” or“tips.”

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present invention isdefined only by the claims as follows.

What is claimed is:
 1. A method of performing a surgical procedure on anindividual, comprising the steps of: a) creating an operative portal inthe individual; b) introducing a trocar within the operative portal, thetrocar including a tubular outer cannula having a distal end, a proximalend and an inner surface and an outer surface, the proximal end of thetubular outer cannula; the trocar also including a tubular inner cannulahaving a distal end, a proximal end and an outer surface, the innercannula being greater in length than the outer cannula, the innercannula being positioned within the outer cannula for longitudinalmovement within the outer cannula; and the trocar also includes aplurality of wings circumferentially attached to the distal end of theinner cannula, the plurality of wings retained between the inner surfaceof the other cannula and the outer surface of inner cannula when theouter cannula is in a first position, each of the plurality of wingsangled away from the other plurality of wings enabling the plurality ofwings being to stabilize the device in or around the operative portalwhen said outer cannula is moved to a second position with said proximalends of both said inner and outer cannulae being adjacent to oneanother; c) moving the outer cannula with respect to the inner cannulato deploy the plurality of wings; d) visualizing the operative portaland the device with the plurality of wings deployed to determine whetherthe plurality of wings are adequate to stabilize the device in theoperative portal; e) moving the outer cannula with respect to the innercannula to retain the plurality of wings between the inner and outercannulae; f) removing the device from the operative portal; g) modifyingthe shape or size of at least one of the plurality of wings based uponthe visualizing step to better stabilize the device within the operativeportal; h) reinserting the device in the operative portal; i) moving theouter cannula with respect to the inner cannula to deploy the pluralityof wings or tips to stabilize the device within the operative portal. 2.The method in accordance with claim 1, repeating steps d) through i)until the device is properly stabilized within the operative portal. 3.The method in accordance with claim 1, further comprising the step ofcutting a portion of at least one of said plurality of wings or tips tomodify the shape or size of at least one of said plurality of wings ortips.
 4. The method in accordance with claim 3, further wherein the stepfor cutting a portion of at least one of said plurality of wings or tipsto modify the shape or length of at least one of said plurality of tipsor wings is based upon a specific joint space in the operative portal.